Sunrise Medical Sunlift Hoist 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sunrise Medical Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-01057-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-21
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Sunrise medical is issuing a product notification following the return of 2 hoists model g175 due to the legs moving in an incorrect “v” position.Distributors and consumers are being notified of important new information relating to conditions of use and revised inspection criteria. the revised information covers conditions of use, daily checks, and ongoing maintenance requirements which will reduce possible damage to the hoist legs which in turn may affect the stability of the hoist.
  • 조치
    Sunrise Medical is providing an updated user manual and advising users of the correct use of the Sunlift hoist. Sunrise Medical is requesting the customers to check the parallelism of the legs of the hoist. If the legs are toed inwards by more than 3 degrees and not parallel Sunrise is requesting the user not to use the hoist in this position. Sunrise Medical is also providing an interface bracket with fitting instructions to ensure the legs will not turn inwards. The parts will be supplied Free-of-Charge. This action has been closed-out on 18/04/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sunrise Medical Sunlift Hoist Models: G150E & G175EARTG # 101030
  • Manufacturer

Manufacturer